Category: Richard Epstein

This week’s twitter round up features a variety of topics from our contributors, from the chemical imbalance theory to infant mortality rates and IVF conception rates.

Frank Pasquale tweeted an article from The Star about the shift of the chemical imbalance theory related to mental illness from an agreed upon medical principle to simply another tactic used by marketers for pharmaceutical companies.

Art Caplan shared two updates regarding current rates of flu vaccination. The first was a retweet of a map graphic showing the “rate of nonmedical vaccine exemptions by state,” and the second was an update based on the records of the Immunization Action Coalition regarding the “now more than 400 organizations with mandatory flu” vaccines for health care workers.

Amitabh Chandra tweeted an update of the infant mortality rates of Pakistan versus India: “In 1960, India and Pakistan had the same infant mortality rate (155/1000). Today, Pakistan’s is 71/1000, which is what India had in 1995.” He also tweeted a Wikipedia article regarding infant mortality driving child mortality.

Stephen Latham tweeted a link to his blog reporting on “US IVF Conceptions at All-time High” which discusses the potential effects of not insuring people for assisted reproduction and encouraging implantations of multiple embryos.

This week’s twitter round up features a variety of topics from our contributors from the hunger crisis in America to the contraceptive mandate and the Lancet/Oslo Commission on Global Governance for Health.

Frank Pasquale tweeted an article from MSNBC about the millions of residents of New York suffering from hunger and the American hunger crisis overall (2/12).

Art Caplan was a guest of Southern California Public Radio, where he discussed the proposal in Rhode Island to mandate flu shots for children from 6 months to 5 years enrolled in preschool or daycare.

In response to a New York Times article about Medicaid expansion, Amitabh Chandra tweeted in support of allowing Medicaid beneficiaries to buy insurance on an exchange.

Stephen Latham tweeted a link to his blog responding to the Lancet/Oslo Commission on Global Governance for Health.

Richard Epstein tweeted his article in “Defining Ideas” about the contraceptive mandate and his view on the strength of the classical liberal case versus the religious case against the law.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Read More

In this Twitter round-up, many of our contributors shared news about end-of-life care and decision making. Some also continued to share their own thoughts, and those of others, about the Affordable Care Act.

Amitabh Chandra posted a NY Times article entitled “How Doctors Die.” The piece discusses some of the contrasts, which some might regard as disparities, between the quality of death experienced by laypeople and that of doctors and their families. (11/20)

Richard Epstein tweeted his blog post about some of the ethical quandaries that still plague “Obamacare.” In “Obamacare’s Death Spiral,” he addresses what he views as constitutional and social complications associated with the ACA. (11/18)

Amitabh Chandra tweeted a brief Wall Street Journal blog post titled “So Many Patients– But Not Enough Doctors to Treat Them!” The author discusses an impending doctor shortage being worsened by the lack of federal funds being appropriated to medical training, and the failure of the ACA to address the problem. (11/18)

Art Caplan posted the NPR story, “Seeking Lung Donors After At Home Death.” Many people who wish to be organ donors actually never fulfill this duty if they die outside the hospital. New advances in lung transplantation, however, may cause this to change. (11/17)

Frank Pasquale tweeted a CBS News article detailing the success of the first few weeks of Medicaid open-enrollment. 440,000 people in 10 states have signed up. (11/12)

Art Caplan touched on the issue of end-of-life care as well this week, when he tweeted the CNN article, “Paralyzed after falling from tree, hunter and dad-to-be opts to end life.” Shortly after learning of his spine injury and paralysis, the man decided not to remain on life support. (11/6)

Bad News On December 14, 2012, the US Food and Drug Administration granted an accelerated approval to the drug Ponatinib, which is used to treat patients with serious and life threatening forms of leukemia. Unfortunately, the risks associated with the use of the drug have proved to be far greater than anticipated. Thus on October 31, 2013, the FDA switched course and asked the manufacturer of ponatinib, Ariad Pharmaceuticals of Cambridge Massachusetts, to suspend marketing and sales of the drug pending the FDA’s further evaluation of the potential costs and benefits of ponatinib’s use. The FDA wants to conduct that study so that it can better determine which patients are the ideal targets for the drug, and which patients are most likely to succumb to its grave negative side effects, “the risk of life-threatening blood clots and severe narrowing of blood vessels.”

Accordingly, the ever-prudent FDA immediately recommends the adoption of a three part program. First, no new patients should begin treatment with the drug. Second, those who are using the drug who are not responding to it should immediately cease use. And third, those patients who are responding favorably to the drug should be allowed to continue its use if their health care professionals believe that the potential benefits from the drug use justifies their filing for a “a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues.” Not surprisingly a recent New York Times Editorial takes the view that the FDA has set up the right process for dealing with this problem by allowing physicians and other health care professionals to go through a “streamlined” process to continue drug use where they think that the anticipated benefits exceed the anticipated costs.

Whose Cost Benefit Analysis? Both the FDA and the Times have done the wrong cost benefit analysis. For starters, all the information about the adverse effects of ponatinib are in the public domain, available to all professionals who prescribe the drug. If the FDA had done nothing other than republish the conclusion of the recent studies, we can be confident that the serious risks associated with its use would quickly work themselves through the system. The amount of the drug prescribed for established and new patients would drop, given the increased revelation of the risk. Higher cost means lower use.

This week, our contributors tweeted quite a bit about the Affordable Care Act, but also about vaccination, the cost of extending life, and the budgetary impact of preventive health policy.

Amitabh Chandra (@AmitabhChandra2) tweeted the piece “The Cost of Living,” a New York Magazine article about the dilemma posed by very expensive cancer drugs that extend life only by a few dozen days. His opinion on the article: “If there is only one article that you read on healthcare this year, make it this one.” (10/22)

Frank Pasquale (@FrankPasquale) tweeted Paul Krugman’s blog post, “Maybe Economics is a Science, but Many Economists are not Scientists.” Krugman raises the question of whether economists are actually using the evidence garnered in their studies to inform policy debates, using healthcare as an example. (10/21)

Adrian Gropper (@agropper), our newest contributor, tweeted his own blog post: “State Surveillance Endangers the Affordable Care Act: A Case Study.” He uses Massachusetts as a lens to discuss the issues caused by state monitoring of individual health information. (10/18)

Art Caplan (@ArthurCaplan) tweeted a BBC report that a judge in the UK ordered two sisters to receive the MMR vaccine. The ruling represents the latest perspective on the benefits of the vaccine versus its risks. (10/17)

Amitabh Chandra (@AmitabhChandra2) tweeted a report by the New England Journal of Medicine on the effect of cigarette taxes on the Federal budget. The analysis, performed by the Congressional Budget Office, highlights the complexity of determining the effects of health policy on the deficit. In Chandra’s opinion, it “exposes [the] sloppiness of prevention arguments.” (10/17)

Richard Epstein (@RichardAEpstein) tweeted his blog post, “The Obamacare Train Wreck,” about his take on how to improve the Affordable Care Act. In the post, he touches on ideas to “fix” the exchanges, the employer mandate, the coverage structure, etc. (10/14)

This round-up features our bloggers’ key tweets from the past two weeks, ranging from the Affordable Care Act to issues of life and death:

Frank Pasquale tweeted the article, “40 Percent of Doctor Practices Unsure About Obamacare Exchanges.” According to the author, more than 80% of doctors participating in a study were unsure about how they would be paid by the exchange plans, and 40% don’t know if they’ll accept the plans at all. (10/8)

Art Caplan posted the article “Euthanasia for emotional pain: Mercy or a ‘culture of death’?” The harrowing piece continues the conversation about the ethics of assisted suicide, this time through the lens of a transgender man’s story. (10/7)

Michelle Meyer tweeted a blog post by Josiah Neeley, called “How to Avoid Defaultmageddon: Randomize Obamacare.” Written before the government shutdown, it discusses the potential utility of allowing the Affordable Care Act to continue as planned in some states but not in others, in order to observe its effects. (10/3)

Richard Epstein tweeted his piece, “Government overreach threatens lives.” In light of an appeal of the 2012 decision in Regenerative Sciences LLC v. United States, he expresses the opinion that the FDA’s decision to review each individual stem cell procedure performed is bad policy. (10/2)

Stephen Latham tweeted about his appearance on the Melissa Harris-Perry show on MSNBC. He was featured as a discussant in a conversation about the book “Knocking on Heaven’s Door: The Path to a Better Way of Life” by Katie Butler, which addresses the idea that a longer life is not necessarily a better one. (9/28)

A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large. That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution of drugs and medical devices in the United States, which it all too often overuses.

That case examined the line between the regulation of pharmaceutical products on the one hand and the practice of medicine on the other. It is well established that the FDA has power over the former, but lacks power over the latter. That distinction is of no small consequence because it allows, for example, for the rise of an extensive market in “off-label use” by physicians of drugs for purposes for which they have not received FDA approval. This class of drug use is very large, and in cancer cases is thought to be more common than treatment using FDA-approved products.

The persistence of off-label drug use should caution people about allowing the FDA to exert extensive control over the drug licensing process. It could be that the thousands of physicians, hospitals, and patients that use drugs off-label have, time after time, all made some major mistake. Or it could just be possible that the accumulated level of institutional knowledge post-release demonstrates that the FDA has been too restrictive in its decisions as to whether a new drug should be allowed into the marketplace in the first instance. The FDA is heavily incentivized to be tough in its approval process lest it take heavy criticism for the all-too-visible injuries that may be caused by approved drugs. But in the social calculus, the individual losses that occur to people who are denied treatment by the heavy-handed actions of the FDA count every bit as much. Yet these diffuse losses, often undocumented, bring much less heat to the FDA, which accordingly is prepared to shrug them off as a cost of supplying people the “protection” that is so central to the FDA mandate.

As another way to keep you up to speed on what’s happening in the world of health policy, we’ll be compiling relevant tweets from our bloggers and posting them here on a bi-weekly basis. Take a look:

Richard Epstein (@RichardAEpstein) tweeted a policy report from the Manhattan Institute concerning FDA regulation of stem-cell procedures. The report rebuts, among other arguments, the FDA’s position that stem-cell treatments are within its purview of preventing communicable diseases. (9/24)

Frank Pasquale (@FrankPasquale) tweeted an article about potentially limited choice of provider under the new health law. According to the authors, the Affordable Care Act keeps premiums low by restricting the number of doctors and hospitals available to patients. (9/24)

Arthur Caplan (@ArthurCaplan) tweeted about the “exploitation of women in poor, underdeveloped nations for surrogacy,” alongside his post of this article. The piece describes the growing phenomenon of wealthy Chinese families paying American women to be surrogate mothers. (9/23)

Michelle Meyer (@MichelleNMeyer) tweeted an article about Penn State’s decision not to sanction employees for non-compliance in a wellness plan. Employees were previously required to respond to a controversial survey administered by a health management company, or pay a fine. (9/18)

Arthur Caplan (@ArthurCaplan) tweeted a piece about continuing bias against gay blood donors. “Gay-rights advocates are fighting to amend the U.S. ban on blood donations by gay and bisexual men, which dates from the first years of the AIDS epidemic,” the author writes. (9/16)

The entire question of the FDA’s tobacco regulation is likely to spur extended commentary, given the split of opinions between the D.C. Circuit, which knocked out the packaging labels by a divided vote in RJ Reynolds v. FDA, and the earlier decision in the Sixth Circuit, that sustained the regulation. The packaging regulations have to be resolved once and for all on a national level, so the case will go up even, I think, if the D.C. Circuit decides to follow the Sixth Circuit in an en bank opinion. So what then should be done?

The issue is one that I have approached before. In the interests of full disclosure, I am a fierce opponent of smoking, who worked in from the mid-1980s into the early 1990s as a consultant for the tobacco lawyers on tort liability issues. After that time, I worked on a number of other issues, in some instances taking positions adverse to the industry. This particular post is done solely and wholly on my own.

In thinking about this case, much of the doctrinal dispute revolved around the much mooted Central Hudson test used in too many First Amendment Cases.